Absorption and Tolerability of Injectable Administration of Niagen®+, as Compared to NAD+

Not Applicable

Recruiting

• Conditions: Healthy Aging

• Registration Number: NCT06919328
• Lead Sponsor: Nutraceuticals Research Institute

Brief Summary

This study evaluates the subjective effects of injection administration of NR on healthy adult populations.

Detailed Description

The purpose of this work is to explore the tolerability of Niagen®, nicotinamide riboside chloride, a specialized form of vitamin B3, via intramuscular (IM), subcutaneous (SQ), and intravenous-push (IVP) administration, in comparison to NAD+, an active comparator, administered through the same routes.

Study Timeline

• Study Start: 2024-10-31
• Study First Submitted: 2025-03-19
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
• Lives within 100 miles of the NRI study site
• Any gender, aged 40-65, inclusive
• Good general health as evidenced by medical history
• BMI 25-34.9 kg/m2
• Sedentary behavior (defined as <20 minutes per day or 100 minutes per week of moderate to vigorous exercise)
• Demonstrated fatigue (Fatigue Assessment Scale) defined as a below-average score
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
• Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria

• Current diagnosis of any seizure disorder, diabetes or insulin resistance, any kidney or liver disorder, heart disease, anemia, cancer, or Parkinson's disease
• ANY chronic illness (pre-disease state acceptable)
• Out of range phosphate levels at baseline
• BMI less than 25 or greater than or equal to 35
• Pregnancy, trying to conceive, or breastfeeding
• Known allergic reactions to any components of the intervention or related compounds, including any form of B3
• Positive COVID-19 test within 30 days of the study period
• Recent dramatic weight changes (10% change in body weight in the last 6 months)
• Existing usage of a NAD+ or NAD precursor supplement in any form (oral, nasal, patch, or injection/IV administration), including a B-complex supplement, within 60 days of the study, not including multivitamins.
• Introducing a new medication, supplement, investigational drug, or other intervention (including lifestyle changes) within 60 days of the start of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
McGill Pain Questionnaire	1 minute after injection is complete	The MPQ contains 78 pain related terms to identify the quantity and type of pain experienced. This multi-dimensional tool has three components; sensory, cognitive, emotional. Higher scores indicate higher levels of pain.
Subjective Discomfort	1 minute after injection is complete	Subjective discomfort is measured using open-ended questions to qualitatively assess participant comfort during injection.

Secondary Outcome Measures

Name	Time	Method
C-reactive protein	baseline, 90 minutes post injection, day 10	CRP in serum
Sed Rate	baseline, 90 minutes post injection, day 10	erythrocyte sedimentation rate through whole blood
plasma viscosity	baseline, 90 minutes post injection, day 10	Plasma viscosity was measured through blood plasma.

Trial Locations

Locations (1)

Nutraceuticals Research Institute; 🇺🇸 Huntsville, Alabama, United States